Successful clinical development. Period.

Clinical Development

Clinical development must have a clear strategy driven by success criteria that are meaningful for patients. We can help to find the best possible way to demonstrate the efficacy and safety of your pharmaceutical or drug-device combination product.

Due Diligence

Before investing in an asset, you need to understand risks and benefits, although not being an expert in respiratory or sleep medicine. This is where ACliRA comes into play and can provide a comprehensive analysis of strengths, weaknesses, opportunities, and threats of the asset you are interested in.

Strategic Advice

You have a brilliant therapeutic approach, a new compound, or a really innovative medical device, but no idea how to bring this to the market? Talk to us about how to defend your idea with regulators and ensure readiness for clinical trials.

Medical Monitoring

When you as a sponsor conduct a clinical trial, you want to be sure that an adequate patient population is recruited, and that sthe afety of participants is monitored 24/7 to obtain reliable trial results. Sponsor oversight is not just a phrase to you, but the essence of your responsibility. We provide trustworthy and independent medical monitoring, driven primarily by the scientific interest in your clinical trial. We can offer comprehensive medical monitoring for your clinical trial in various EDC environments. Get a quote today by contacting us directly.

Clinical Evaluation (MDR)

If you are developing a medical device product, the most recent medical device regulation in the EU (MDR) requires you in many cases to conduct own clinical investigations with your new device in order to obtain CE marking.
The FDA in the USA also requires a thorough investigation of a medical device before it will be cleared for use.
We can assist you in both regulatory frameworks to ensure compliance with legal requirements.

Legal Representation in the European Union

If you are a sponsor not based in the EU, you must have a legal representative to conduct clinical trials (CTR) or clinical investigations (MDR) in the EU. ACliRA can stand by your side without the need to establish your own company, yet ensure you do not miss any obligation or responsibility as a sponsor.
How it works

Three Easy Steps

1

Understand the Asset/Approach

Before giving advice, we need to understand your assets and approach. This requires some time and effort, but it will pay back in the later steps, because a well-informed proposal can be made.
2

Create a Development Strategy

Once we understand what your goals are, we can create a development strategy up to the point you define. With this, you can e.g,. talk to investors and convince them to provide funding for your project.
3

Implement strategy and execute

When you are ready to initiate your clinical trial, we are here to support you in creating all necessary documents for regulatory submissions to CTIS or EUDAMED. Moreover, we can also help evaluate different CROs suitable for your needs, monitor study execution, provide medical monitoring of your study, etc. When the trial is finished, we are here to support the writing of the clinical study report and/or device study report according to current legislation.

Together We Can Do More

Drop us a note today!